Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01203488 · ClinicalTrials.gov registry record · Phase 1
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
A Phase 1 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 807
- Enrollment target
NCT01203488: Completed Phase 1 study, sponsored by NICHD Neonatal Research Network.
NCT01203488 is a Phase 1 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 807 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1245% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01203488, a Phase 1 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 807 participants
- Enrollment target
Study Summary
This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the Vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.
Primary Outcome
Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age.
Interventions
- OTHER Sham Procedure
- DRUG Vitamin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 807 participants |
| Start Date | 1996-01 |
| Est. Completion | 1999-07 |
| Phase | Phase 1 |
What the finished NCT01203488 record still lists
NCT01203488 is an interventional study that assigns participants to a tested intervention. The registered 807 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1245% higher).
The record links to 0 conditions, and to 2 interventions - of which Sham Procedure is the first listed.
NCT01203488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01203488 about?
NCT01203488 is a clinical study titled "Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants". This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who ...
What is the current status of trial NCT01203488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 807 participants. The study started on 1996-01. Estimated completion is 1999-07.
What interventions are being tested in trial NCT01203488?
The interventions under investigation include: Sham Procedure (OTHER), Vitamin A (DRUG).
Who is sponsoring clinical trial NCT01203488?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01203488's enrollment target sits among peer trials
807 12th of 2000 higher than 1,989 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06529094 · 808 participants · NA
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
- NCT04613596 · 806 participants · Phase 2
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
- NCT06065098 · 806 participants · NA
Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
- NCT05519085 · 810 participants · Phase 3
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia